Positive data from trial of IN.PACT Admiral balloon in PAD-Medtronic

Data shows the IN.PACT Admiral drug-coated balloon from Medtronic provides a consistently favorable effect in the treatment of Peripheral Artery Disease in leg arteries above the knee in patients with Diabetes. The data comes from the IN.PACT SFA landmark study of the investigational medical device, which is under review by the FDA.

The IN.PACT SFA trial enrolled 331 subjects at 57 sites across Europe and the United States. All study subjects were randomized to treatment with the drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). The clinically driven target lesion revascularization (CD-TLR) rates at 12 months were 2.4 percent for the Drug Coated Balloon group and 20.6 percent for the percutaneous transluminal angioplasty group, a highly statistically significant difference. CD-TLR accounts for repeat procedures due to recurrent symptoms related to the treated lesion.

In addition to disease severity, other baseline characteristics including diabetes (40.5% vs. 48.6%) and hypertension (91.4% vs. 88.3%), as well as mean lesion length (8.94 cm vs. 8.81 cm) and percent of total occlusions treated (25.8% vs. 19.5%), were similar between the two groups, with no statistically significant differences. Clinical outcomes, however, significantly favored the DCB group. Data were presented at the Vascular InterVentional Advances 2014 (VIVA 14) meeting.